Pharmacyclics, LLC

Manager, Regulatory Affairs

Location
Sunnyvale, CA, United States
Posted
Sep 13, 2018
Ref
2481
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

General Position Summary/Purpose:

The Manager under the accountability of the Senior Director, Regulatory Affairs, helps lead teams by providing regulatory strategy and support to global development. He/she is expected to help support teams and efforts around major filing activities and Health Authority (HA) interaction and meetings, attend and provide regulatory support to other departments, project teams and committees. Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, NDAs/MAAs, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions. This position may have direct interaction with FDA representatives.

Key Accountabilities/Core Job Responsibilities:

  • Represents RA at project team meetings and manages/oversees regulatory workflow between departments as well as CROs as required at the study team level for management of CTAs, IMPDs.
  • Lead and facilitate US filing activities IND/NDA submissions including but not limited to orphan drug designation, preparation and submission of meeting requests/briefing books and response to information requests
  • Expected to critically review and provide strategic input on regulatory filing documents (eg, eCTD Module 1 label, Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).
  • Coordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations team
  • Oversee development of dossier filing plan and associated timelines with regulatory operations
  • Provide oversight to study teams regarding overall regulatory strategy to ensure compliance with global HA regulations/guidelines and company SOPs to ensure successful and high quality regulatory applications
  • Direct interaction with FDA as point of contact for IND/NDA. Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
  • Lead development and authoring internal procedures and company SOPs ensuring compliance with existing regulations and guidelines.
  • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues
  • Additional Functions:
    • Foster teamwork and improve intra-/inter-departmental communications
    • Collaborate with external parties, (eg, Alliance partner companies and investigator-sponsors, on regulatory strategies for IND and CTA filings)
    • Supervise regulatory staff and mentor/train associates in carrying out responsibilities. Coordinate associates' activities and career development
    • Position will regularly interact with all departments and all levels within a department
    • Position may have direct reports

Qualifications:

  • Specialized knowledge of regulatory activities including but not limited to submissions to HAs, including NDA/ BLA/MAA, INDs/CTAs, IND/CTA amendments, safety reports, pre-meeting packages, and post-approval submissions
  • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
  • Ability to work either independently with minimal direction separately or within project teams, committees, etc. to attain group goals
  • Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
  • Thorough working knowledge and understanding (application of knowledge/experience) of FDA/EMA guidance and regulations, especially for drug therapeutics
  • Ability to learn and assimilate scientific information
  • Flexible attitude with respect to work assignments, and willingness to learn

Experience:

  • Minimum three years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including knowledge of all aspects of the drug development process
  • Strong scientific background and experience in critical review and interpretation of scientific/clinical data
  • Experience/competence writing and leading regulatory documents (eg, meeting requests/briefing book activities)
  • Prior experience working on US labeling activities highly desirable
  • Prior work experience in hematology/oncology highly desirable
  • Previous experience in interpretation of FDA/EMA regulations, guidelines, policy statements, etc.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross functionally
  • Ability to guide, train, and supervise and mentor personnel within regulatory affairs department

Education Requirements (degree, certifications, etc.): Include must have and preferred

  • B.S., advanced degree in life sciences preferred (PhD, PharmD, BSN, MD, MS)
  • RAC certification or Masters in regulatory sciences a plus


Equal Opportunity Employer Minorities/Women/Veterans/Disabled